BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE LENS CARE SOLUTION

    MDR report key: 1801207 · Received August 11, 2010

    Report

    Report Number
    8020392-2010-00009
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 13, 2010
    Manufacturer
    CIBA VISION STERILE MANUFACTURING
    Product Code
    LPN
    PMA / PMN Number
    K030522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS CONSIDERED AS A POSSIBLE PERMANENT REDUCTION IN VISUAL ACUITY. AS THERE WAS NO PRODUCT RETURNED OR LOT INFORMATION PROVIDED, NO DETAILED INVESTIGATION CAN BE PERFORMED.(B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM AN EYE CARE PRACTITIONER THAT A PATIENT EXPERIENCED SUPERFICIAL PUNCTATE KERATITIS (SPK) ASSOCIATED WITH USE OF LENS CARE SOLUTION. NO MEDICATION WAS REQUIRED. AT FOLLOW-UP VISIT, THE EVENT WAS NOTED AS WORSENING WITH REDUCED ACUITY AND SPK NOTED "LIMBUS TO LIMBUS." APPLIED UNSPECIFIED OINTMENT AND PRESCRIBED UNSPECIFIED DROPS. FOLLOW-UP INFORMATION RECEIVED FROM ECP ON (B)(6) 2010 INDICATED THAT AT DAY 5 OFFICE VISIT IMPROVEMENT NOTED WITH BANDAGE LENS, LESS PAIN AND BEST CORRECTED ACUITY OF 20/25. INITIAL SEVERE PUNCTATE STAINING, NOW MORE CENTRAL. VIGAMOX TAPERED TO 1XDAY AND CONTINUE LUBRICATING DROPS. NEXT FOLLOW-UP VISIT NOTED PATIENT STILL COMPLAINING OF "SCRATCHINESS AND CENTRAL CLOUDING." NO VISUAL ACUITY INFORMATION WAS PROVIDED. REQUEST HAS BEEN MADE FOR ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR CARE LENS CARE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN CIBA VISION STERILE MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability